Effect of Reproductive Tract Microbiota on Pregnancy Outcome in IVF/ICSI

• Conditions: Infertility; Recurrent Implantation Failure; Recurrent Miscarriage

• Registration Number: NCT04293068
• Lead Sponsor: Peking University Third Hospital

Brief Summary

A single center，observational cohort study to explore the relationship between reproductive tract microbiota and pregnancy outcome in the patients accepted IVF/ICSI. To investigate whether there is a correlation between reproductive tract microbiota and IVF/ICSI outcomes. Whether there are differences in reproductive tract microbiota (such as vagina, follicular fluid, uterine cavity, etc.) in patients with different pregnancy outcomes.

Detailed Description

A single center，observational cohort study will enroll 120 infertile participants and then divide them into 3 groups: 1)Male infertility；2)Recurrent implantation failure; 3)Recurrent spontaneous abortion. The study will last for 1 year and recruit participants in Reproductive medicine center of Peking university third hospital. Each participant will be followed up for at least 1 year. Collect samples and record information at the first month, then follow-up 2 months to record the pregnancy outcomes. DNA will be extracted from the samples and then have sequence to figure out the compositions of microbiota.

Study Timeline

• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-03
• Study Start: 2020-08-18
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-30
• Last Update Posted: 2021-02-02
• Primary Completion: 2021-07
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1. The sampling cycle of all samples requires no use of glucocorticoids, antibiotics and vaginal drugs within the cycle of this month; No cervical treatment within a week; No irrigation, asexual life within 5 days; Strict contraception in this month;
2. Male infertility (Related tests were normal, because the male factor alone required the first IVF/ICSI cycle; Follow-up of included patients was conducted to determine whether embryo transplantation was performed, and the score of transferred embryos was recorded, and the final control group would be confirmed after achieving clinical pregnancy) OR Recurrent implantation failure (Previous ≥3 consecutive embryo transfer failures) OR Recurrent spontaneous abortion (≥2 consecutive spontaneous abortions or embryo damage)

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Exclusion Criteria

1. Acute genital tract inflammation (including vagina, cervix, endometrium and pelvic cavity)
2. Previous diagnosis of intrauterine adhesion or mechanical damage to the endometrium; drugs and surgery can not restore the function (endometrium thickness <7mm in the window period before transplantation)
3. Untreated hydrosalpinx, submucosal or >4cm intramuscular uterine fibroids, adenomyosis, stage III-IV endometriosis confirmed by surgery, endometritis diagnosed by pathology and other definite factors might affect implantation
4. Chromosomal abnormalities in couples may lead to miscarriage, fetal malformation and other diseases
5. Previous examination indicated the existence of DOR (FSH≥9U/L and/or AMH ≤1.1ng/ml and/or AFC≤5-7)
6. Those with polycystic ovary syndrome, high prolactinemia and other ovulation disorders
7. Those with congenital adrenal hyperplasia, hypothyroidism/hyperthyroidism, diabetes, metabolic syndrome and other endocrine and metabolic diseases
8. BMI less than 18 or more than 25
9. Previous autoimmune diseases such as anti-heart coagulation syndrome, sjogren's syndrome and rheumatoid arthritis
10. Prethrombotic hypercoagulability or family history of thrombosis
11. Female genital tract deformities (whether or not surgically corrected)
12. Those within the programme of oocyte or sperm donor
13. Those with previous history of various types of cancer or serious systemic diseases (such as heart, lung and blood diseases) or mental diseases

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	4 weeks after embryo transfer	One or more observed gestational sac or definitive clinical signs of pregnancy under ultrasonography at 4 weeks after embryo transfer (including clinically documented ectopic pregnancy)

Secondary Outcome Measures

Name	Time	Method
Microbiota ratio	About 2 months later after samples collection	The ratio of microbiota within 3 groups will be acquired and analyzed by Metagenomics and 16SrRNA sequence. Shannon's diversity index and Chao richness will be used to measure the different ratio of microbiota within these 3 groups
Available embryo	72 hours after oocyte retrieval	Number of embryos ≥4 cells and ≤30% fragmentation on day 3 observation will be observed and counted under microscope
Ongoing pregnancy rate	10 weeks after embryo transfer	Presence of a gestational sac and fetal heartbeat after 10 weeks of gestationwill be monitored by ultrasound
Live birth rate	After 24 weeks of gestation	A delivery of one or more living infants (≥24 weeks gestation or birth weight more than 1,000g) will be followed up via telephone
Good quality embryo	72 hours after oocyte retrieval	Number of embryos with ≥6 cells and ≤30% fragmentation developed from 2PN embryos on day 3 observation
Oocyte retrieval	36 hours after HCG injection	Number of oocytes retrieved for use in the following IVF-ET procedure will be counted under microscope
Fertilization rate	16-20 hours after oocyte retrieval	Number of zygotes with 2 PN will be observed and counted under microscope
Endometrium thickness	On the day of embryo transfer	Transvaginal Ultrasonography will be used to measure the endometrium thickness on the day of embryo transfer
Implantation rate	30 days after embryo transfer	Number of gestational sacs observed per embryo transferred will be observed under ultrasonography

Trial Locations

Locations (1)

Peking university third hospital; 🇨🇳 Beijing, Beijing, China